Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with informed consent 2. Age >18 yrs and 3. COVID-19 RT-PCR positive 4. RT-PCR done less than 7days 5. Moderate to severe case (NEWS 2 score- more than or equal to 5) 6. SPO2- 24 per minute in Room air 7. KPS >60 8. HRCT suggestive of Interstitial pneumonia with CORADS 4-6 and CT severity score of moderate to severe. 9. Patient able to lie supine for Radiation therapy
Exclusion criteria
Exclusion criteria: 1. Patient on mechanical ventilator support 2. Hemodynamically unstable patient 3. Pregnancy and lactating mothers 4. Known prior systemic use of the following drugs: Bleomycin, Carmustine, Methotrexate, Busulfan,Cyclophosphamide, or Amiodarone 5. History of lung lobectomy or pneumonectomy. 6. History of receiving immunotherapy within the past 6 months. 7. History of Chronic obstructive pulmonary disease, Severe Left Ventricular Dysfunction and patients on beta blockers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Low dose radiation therapy (LDRT) on oxygen dependence in moderate to severe COVID 19 pneumonia with National Early Warning Score(NEWS-2).Timepoint: National Early Warning Score(NEWS-2) on Day 3, Day 7 and Day 14 compared with baseline(Day 0). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the clinical efficacy of LDRT interms of:- 1. Radiological response using CT Severity Score, 2. Effect on inflammatory markers(CRP, LDH, IL6, D dimer, Ferritin). 3. Length of hospital stay in moderate to severe COVID 19 patients 4. Requirement of ventilator support and ICU admission 5. Acute toxicity assessed with RTOG toxicity grading and CTCAE V.5.0. Timepoint: 1. Radiological response monitored with HRCT at baseline, Day 7 and Day 14 from the day of LDRT. 2. Covid-19 biomarkers- CRP, LDH, IL6, D-dimer, Ferritin levels assessed at baseline, Day 7 and Day 14. 3. Acute Radiation Toxicity assessment done on Day 3, Day 7, Day 14 using RTOG toxicity Grading and CTCAE V.5.0. | — |
Countries
India
Contacts
Karnataka Cancer Therapy And Research Institute